Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors

OBJECTIVES:

Primary

- Determine the incidence of vincristine-induced peripheral neuropathy in pediatric
patients with lymphoma, leukemia, or solid tumors.

Secondary

- Compare the safety of glutamine vs placebo in these patients.

- Compare the efficacy of glutamine vs placebo in reducing the progression and/or
resolution of vincristine-induced peripheral neuropathy in these patients.

- Compare the effect of glutamine supplementation vs placebo on chemotherapy-related
toxicities in these patients.

- Compare the effect of glutamine vs placebo on measures of quality of life in these
patients.

- Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor
and glutamine levels in these patients.

- Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro.

OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Beginning 1 week after administration of vincristine chemotherapy, patients
receive oral glutamine twice daily on days 1-21.

- Arm II: Beginning 1 week after administration of vincristine chemotherapy, patients
receive oral placebo twice daily on days 1-21.

Patients in both arms undergo neuropsychological and clinical neurological assessment, blood
collection for serum marker (e.g., serum glutamine and nerve growth factor) analysis, and
quality of life assessment on days 1, 21, and 42.

After completion of study treatment, patients are followed for an additional 21 days.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Diagnosis of any of the following:

- Acute lymphoblastic leukemia

- Non-Hodgkin's lymphoma

- Ewing's sarcoma

- Wilms tumor

- Rhabdomyosarcoma

- Newly diagnosed disease

- No recurrent disease

- No primary or metastatic CNS tumors

- Must have documented, clinically mild peripheral neuropathy identified by 1 of the
following criteria:

- Clinically progressive neurologic findings as defined by an increase in 1
toxicity grade by NCI CTC v3.0 on clinical exam

- Clinically progressive neuropsychological findings as determined by
neuropsychological examination and defined by the following:

- At least ½ standard deviation from the baseline score on any of the
following 3 neuropsychological instruments that measure both fine and gross
motor functioning:

- Symbol Digit Modalities Test

- Hand Dynamometer Test (Grip Strength Test)

- Purdue Pegboard Test

- Currently receiving an expected cumulative dose of ≥ 15 mg/m^2 of vincristine over a
30-week period

- Maximum prior cumulative dose of vincristine ≤ 8 mg/m^2

- No preexisting neurologic disease, including grade II, III, or IV neurological status
by NCI CTC v3.0 on clinical exam

PATIENT CHARACTERISTICS:

- No hepatic encephalopathy or hyperammonemia

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics